A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients.

NCT06512116 | Recruiting Phase 1 DMC

• 1 other identifier: SIBP-A17-I
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A17 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Conditions

Advanced Solid Tumor

Keywords

Advanced solid tumor; Her2-ADC; Safety; Efficacy; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicity (DLT)

  During the dose escalation phase, the first treatment cycle (21 days after the first dose) after the subject's administration was determined by the investigator to have occurred events related to the investigational drug as specified in the protocol.

  Day 126

• Maximum tolerated dose (MTD)

  The maximum tolerated dose (MTD) refers to the highest dose at which DLT does not occur in \<1/3 of subjects or ≤ 1/6 of subjects during the DLT observation period.

  Day 260

• Recommended Phase II Dose (RP2D)

  Recommended Phase II Dose The optimal dose for phase II clinical trial research obtained based on clinical trial results of phase I and literature review.

  Day 518

• Adverse Events (AE)

  That is adverse events, any adverse events that occurred to the participant during the study period.

  28 days

Secondary Outcomes (7)

• AUC (Area Under The Plasma Concentration Versus Time Curve)

  15 days

• Cmax (Peak Plasma Concentration)

  15 days

• ORR(Objective Response Rate)

  5 months

• DCR (Disease control rate)

  5 months

• PFS(Progression-free survival)

  5 months

Study Arms (1)

SIBP-A17

EXPERIMENTAL

SIBP-A17 is an Her2-ADC drug.

Drug: SIBP-A17

Interventions

SIBP-A17 DRUG

Strength: 1, 2, 4, 5, 6 or 8 mg. Intravenous infusion administration, with a treatment cycle of every 21 days, administered once on the first day of each cycle. The dose escalation stage, 1mg/kg and 2mg/kg were subjected to accelerated titration, where the safety was evaluated within 21 days after the first administration to one subject. If dose-limiting toxicity (DLT) occurred, the traditional "3+3" dose escalation method was immediately switched. If DLT does not occur, the next dose group will be explored, and the dose exploration starting from 4mg/kg will adopt a "3+3" dose escalation design.

Also known as: Her2-ADC

SIBP-A17

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range of 18 to 75 years old (including boundary values), gender not limited.
• The clinical diagnosis of enrolled subjects should meet the following criteria:
• Dose escalation stage:
• Advanced solid tumor subjects confirmed by histology or cytology to have no standard treatment plan or ineffective or intolerant standard treatment plan.
• Dose expansion stage:
• Cohort 1: Late/unresectable and/or metastatic breast cancer with low HER2 expression (IHC1+or IHC2+/FISH -) after standard treatment failure or intolerance.
• Cohort 2: HER2 positive (IHC3+or IHC2+and FISH+) local advanced or metastatic digestive system tumors that fail or are not tolerated after standard treatment, including adenocarcinoma of stomach or gastroesophageal junction, colorectal cancer, etc. (pancreatic cancer and biliary tract cancer are excluded).
• Cohort 3: HER2 positive (IHC3+or IHC2+with FISH+) advanced gynecological tumors that have failed or are intolerant to standard treatment, including but not limited to cervical cancer, endometrial cancer, and ovarian cancer.
• Cohort 4: Other advanced solid tumors with HER2 expression that failed or were intolerant after standard treatment were preferentially included but not limited to HER2 positive (IHC3+or IHC2+and FISH+) breast cancer (at least 10 cases included), non-small cell lung cancer, etc.
• Willing and able to provide sufficient fresh collected or archived tumor tissue samples (only applicable during dose expansion phase).
• There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 criteria, CT or MRI). Lesions that have received previous radiotherapy or other local treatments are not considered as target lesions unless there is clear progression of the lesion.
• The Eastern Cooperative Oncology Group (ECOG) score for physical fitness is 0 or Expected survival period ≥ 3 months.
• During the screening period, the main organ functions were basically normal \[no blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the experimental drug\]
• During the screening period, women of childbearing age with negative blood pregnancy test results and reproductive age subjects (including male subjects) who have no pregnancy plans during the trial period and within 6 months after the last dose and voluntarily take effective contraceptive measures.
• Voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• Patients with tumors as specified in the protocol
• Individuals with a history of previous treatment or surgery, or those who have received anti-tumor treatment as specified in the protocol during the planned trial period.
• Individuals with a history of previous illnesses or abnormal conditions as specified in the laboratory examination protocol.
• Screening for individuals with positive Treponema pallidum antibodies during the screening period. Individuals with active hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serosal fluid drainage within 4 weeks before the first administration.
• The screening period is accompanied by severe, progressive, or uncontrolled diseases, and it has been assessed by the researchers that participation in the study would increase the risk for the subjects.
• History of interstitial lung disease/non infectious pneumonia in the past, currently suffering from interstitial lung disease/non infectious pneumonia, or suspected interstitial lung disease/non infectious pneumonia that cannot be excluded through imaging examination during screening.
• Subjects who have experienced severe infections within 4 weeks prior to their first medication. Active infections that have received therapeutic intravenous antibiotics within 2 weeks prior to the first medication. Subjects receiving prophylactic antibiotic treatment can be enrolled.
• Participants who have participated in any clinical trial as subjects within the first 3 months of enrollment (excluding subjects who have only participated in clinical trial screening and have not used the investigational drug).
• According to the judgment of the investigator, there are concomitant diseases (such as severe diabetes, thyroid disease, etc.) that seriously endanger the safety of the subject or affect the completion of the study.
• Individuals with a history of severe allergies to protein products, CHO cell products, other recombinant human or humanized antibodies, or components of the investigational drug.
• Pregnant and lactating women.
• Researchers believe that participants who are not suitable for enrollment.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Cancer Hospital of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Jing Huang, Doctor

  Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dandan Chen, Master

CONTACT

86-021-62800991; ddchen.sh@sinopharm.com

Hao Zhou, Bachelor

CONTACT

86-021-62800991; zhouhao5@sinopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is an open, dose expanding, and indication expanding study.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)